Equinoxe 300-21-15
Equinoxe 300-21-15 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K102951 on 4 Nov 2010 and listed in FDA GUDID since 30 Oct 2015 (UDI-DI 10885862195982), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10885862195982 | Date30 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102951 | Date4 Nov 2010 | StatusActive |
Official records
- AccessGUDID record 10885862195982
- FDA 510(k) database K102951
Across registries
- FDA 510(k) K102951 decided 4 Nov 2010 Active
- FDA GUDID UDI-DI 10885862195982 listed 30 Oct 2015 Listed
Recalls
-
- Terminated Z-2116-2012
- Terminated Z-2119-2012
Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year
Timeline
- Cleared FDA 510(k) K102951
- Recall initiated FDA recalls Z-2116-2012
- Recall initiated FDA recalls Z-2119-2012
- Listed FDA GUDID 10885862195982
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Equinoxe
- Generic name
- Shoulder humeral body prosthesis
- Model / Ref / Catalog
- 300-21-15
- Primary DI / UDI-DI
- 10885862195982
- 510(k) Number
- FDA product code
- KWS, KWT
- GMDN term
- Shoulder humeral body prosthesis
- Device class
- Class II
- Regulation number
- 888.3660, 888.3650
- GUDID distribution status
- In Commercial Distribution